Elsevier

Gastrointestinal Endoscopy

Volume 74, Issue 3, September 2011, Pages 581-589.e1
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
Second-generation colon capsule endoscopy compared with colonoscopy

https://doi.org/10.1016/j.gie.2011.03.1125Get rights and content

Background

Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system.

Objective

To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy.

Design and Setting

Prospective, multicenter trial including 8 European sites.

Patients

This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed.

Intervention

CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day.

Main Outcome Measurements

CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed.

Results

Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients.

Limitations

Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients.

Conclusion

In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.

Section snippets

Patients and methods

A total of 8 European sites participated in this prospective study. Recruitment began August 28, 2009 and ended July 7, 2010. Patients (18-80 years of age) who were scheduled to undergo colonoscopy for either known or suspected colonic disease were enrolled in the study. Indications included colorectal cancer screening; personal history of colorectal cancer or adenomatous polyps and at least 3 years since last conventional colonoscopy; clinical symptoms such as rectal bleeding, positive fecal

Results

The 8 participating centers enrolled 117 patients (mean ± SD age 60 ± 9 years; 72 men). Clinical indications for colonoscopy are provided in Table 1. Eight of 117 patients (6.8%) were excluded from the efficacy analysis for the following reasons: inability to swallow the capsule (1 case), technical failure of the data recorder (2 cases), and capsule technical failure (2 cases). In two cases, the capsule remained in the cecum during the entire procedure, and one patient withdrew consent to

Discussion

Our prospective, multicenter study showed a sensitivity as high as 84% and 88% for ≥6-mm and ≥10-mm polyps, respectively, when comparing CCE-2 with colonoscopy. These results are well in line with the colon capsule endoscopy–sensitivity values of 89% and 88% assessed in the previous Israeli study,8 confirming the high colon capsule endoscopy sensitivity for clinically relevant lesions. Of note, the mean age of the patients included in our study—that is, 60 years—is more similar to that of an

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DISCLOSURE: C. Spada, C. Hassan, H. Neuhaus, J. Deviere, A. Van Gossum, S. Sacher-Huvelin, J-P Galmiche, and G. Costamagna are speakers for Given Imaging Ltd. J. Deviere, J-P Galmiche, and G. Costamagna have received research grants from Given Imaging Ltd. No other financial relationships relevant to this publication were disclosed.

If you would like to chat with an author of this article, you may contact Dr Spada at [email protected].

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